Examples of using Xofigo in English and their translations into German
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The most frequent side effects in patients receiving Xofigo(very common[may affect more than 1 in 10 people]) are.
The approval of Xofigo is based on data from the pivotal Phase III ALSYMPCA(ALpharadin in SYMptomatic Prostate CAncer) trial.
Grade 3 and 4 neutropenia was observed in 2.2% of patients treated with Xofigo and in 0.7% of patients receiving placebo.
The sales gains for our cancer drug Xofigo™ resulted mainly from good business development in Europe and the United States.
Berlin, April 2, 2014- Bayer HealthCaretoday announced that the company has begun to enroll patients in a new Phase III trial with radium-223 dichloride radium-223, Xofigo®.
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Radium-223 dichloride has been approved under the brand name Xofigo® in more than 40 countries worldwide, including the U.S. and the EU.
To achieve our medium-term growth targets, we are continuing to rely on marketing our recently launched products Xarelto™, Eylea™,Stivarga™, Xofigo™ and Adempas™.
The overall safety profile of Xofigo is based on data from 600 patients treated with Xofigo in the phase III study.
In EOD4(“superscan”) patients, thrombocytopenia(all grades)was reported in 19.6% of patients treated with Xofigo and in 6.7% of patients receiving placebo.
The alpha particle range from Xofigo is less than 100 micrometers(less than 10 cell diameters), which minimises damage to the surrounding normal tissue. Xofigo is approved in the U. S.
Grade 1 and 2 injection site reactions, such as erythema, painand swelling, were reported in 1.2% of patients treated with Xofigo and in 0% of patients receiving placebo.
Radium-223 has been approved under the brand name Xofigo® by the European Commission for the treatment of adults with CRPC, symptomatic bone metastases and no known visceral metastases.
If you are taking calcium, phosphate and/or Vitamin D, your doctor will carefully considerif you need to temporarily stop taking these substances before you start treatment with Xofigo.
We once again recorded substantial sales gains for our cancer drug Xofigo™, with business benefiting from a successful market launch in Japan and growth in the United States and Europe.
The limited data available do not suggest any major differences in the blood cell production of patients receiving chemotherapy after treatment with Xofigo compared with those who did not receive Xofigo.
Efficacy and Safety Data Supporting Xofigo ApprovalThe approval of Xofigo(radium 223 dichloride, radium 223) is based on data from the pivotal Phase III ALSYMPCA(ALpharadin in SYMptomatic Prostate CAncer) trial.
New treatment for adults with castration-resistant prostate cancer,symptomatic bone metastases and no known visceral metastases/ Xofigo significantly extended overall survival in Phase III ALSYMPCA study.
Our five recently launched products- Xarelto™, Eylea™,Stivarga™, Xofigo™ and Adempas™- again contributed to this pleasing performance with combined sales of €4.2 billion, compared with €2.9 billion in 2014.
The results from the phase III ALSYPMCA study regarding time to external beam radiation therapy(EBRT) for pain relief andfewer patients reporting bone pain as an adverse event in the Xofigo group indicate a positive effect on bone pain.
In case there is no recovery in these values within 6 weeks after the last administration of Xofigo despite receiving standard of care, further treatment with Xofigo should only be continued after a careful benefit/risk evaluation.
Xofigo was compared with placebo(a dummy treatment) as an addition to standard care in a main study involving 921 men with cancer of the prostate that had spread to the bones and for which suppression of male hormones using medicines or surgery did not work.
The European, Japanese and U.S. health authorities have concluded their review of the data from the ERA-223 trial andconfirmed overall that the risk-benefit profile of Xofigo™(radium-223 dichloride) remains positive in the approved indication, subject to the required changes to the respective labeling.
Radium-223 has been approved under the brand name Xofigo® in more than 40 countries worldwide, including the U.S. and the EU. About Oncology at BayerBayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments.
If you suffer from untreated spinal cord compression or if it is thought likely that you are developing spinal cord compression(pressure on the spinal cord nerves which can be caused by a tumour or other lesion), your doctor will first treat this disease withstandard treatment before starting or continuing treatment with Xofigo.
The clinical safety and efficacy of Xofigo have been evaluated in a double-blind, randomised, multiple dose, phase III, multicentre study(ALSYMPCA; EudraCT 2007-006195-1) in castration-resistant prostate cancer patients with symptomatic bone metastases.
Overall, the frequency of grade 3 and 4 neutropenia was lower in patients that did not previously receive docetaxel(0.8% in patients treated with Xofigo versus 0.8% in patients receiving placebo) compared to patients that previously received docetaxel 3.2% in patients treated with Xofigo versus 0.6% in patients receiving placebo.
Furthermore, the anti-cancer drug Xofigo(radium 223 dichloride) is a first-in-class alpha-pharmaceutical which is designed for use in prostate cancer patients with'bone metastases'(secondary cancers in the bone) to treat the cancer in the bone and to help extend their lives.
Xofigo is used when medical or surgical castration(stopping the production of male hormones in the body using medicines or surgery) does not work, and when the cancer has spread to the bones and is causing symptoms such as pain but is not known to have spread to other internal organs.
Based on the excellent Phase III results for Xofigo in patients with castration resistant prostate cancer and symptomatic bone metastases Bayer is looking to expand the use of Xofigo to earlier stages of the disease, and plans to initiate a Phase III study in combination with the novel anti-hormonal agent abiraterone.
The complete SmPC of Xofigo is provided as a tear-off section at the end of the printed leaflet in the product package, with the objective to provide healthcare professionals with other additional scientific and practical information about the administration and use of this radiopharmaceutical.